Kornimate/medical-research-clean huggingface dataset:
phase i/ii trial of letrozole and sorafenib in post-menopausal hormone-receptor + breast cancer

Conditions: Metastatic Breast Cancer

Summary: letrozole is an aromatase inhibitor that is approved in the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer. sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. this phase i/ii trial is studying the side effects and best dose of sorafenib when given in combination with letrozole and to see how well they work in treating postmenopausal women with metastatic breast cancer.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed invasive breast cancer 2. stage iiib, iiic with t4 lesion or stage iv disease 3. breast cancer must be er-positive and/or pr-positive 4. age ³ 18 years of age 5. ecog performance status 0, 1 or 2 6. able to swallow and oral medication 7. adequate end organ function 8. written informed consent exclusion criteria: 1. prior hormonal therapy for metastatic disease 2. prior chemotherapy for metastatic disease 3. prior treatment with sorafenib 4. brain metastases or leptomeningeal disease 5. evidence or history of bleeding 6. thrombolic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months

Keywords: breast cancer postmenopausal women with hormone receptor-positive locally advanced breast cancer
bioclinical profile of adenotonsillar hypertrophy in the pediatric population

Conditions: Enlargement of Tonsil or Adenoid

Summary: adenotonsillar hypertrophy is the principal cause of obstructive sleep apnea of childhood, yet little is known with regard to its pathophysiologic and molecular mechanisms. the present trial examines potential bioclinical markers of the disease.

background: tonsils and adenoids comprise the main bulk of waldeyer's ring, which is commonly enlarged in childhood, until the age of 11. obstructive sleep apnea caused by adenotonsillar hypertrophy is a major contributing factor to cardiorespiratory morbidity in the pediatric population. it is also responsible for otitis media with effusion, the most frequent cause of children's hearing loss. even so, there is scarce knowledge of its molecular pathogenesis. objective: identification of clinical/molecular markers of adenotonsillar enlargement and investigation of their participation in the process of tissue hypertrophy. methods: a prospective cohort of children with adenotonsillar hypertrophy were recruited starting on 02/01/2017 and ending on 12/22/2017. demographic and clinical data including age, gender, sleep apnea severity, tonsillar size, presence of middle ear effusion, family history, review of systems as well as tympanometric and complete blood count results were recorded. blood samples and tissue specimens from the therapeutic adenotonsillectomy procedure were archived for future analyses. children with chronic tonsillitis and/or adenoiditis, who also underwent excision of tonsils and/or adenoids served as study controls. informed consent was obtained from parents of all study participants.

Eligibility criteria:
inclusion criteria: * available history and physical exam findings * available complete blood count and tympanometry at admission exclusion criteria: * previous tonsillectomy and/or adenoidectomy. * previous ear surgery. * acute infection during the past month. * active severe systemic disease.

Keywords: obstructive sleep apnea tonsillitis middle ear effusion pathophysiology score
mindfulness and yoga or resistance exercise training fpr parkinson's patients

Conditions: Resistance Training; Yoga

Summary: the investigators propose to compare the effects of a 16-week specially designed yoga program to a power-based resistance training program on affect trait mindfulness, anxiety, depression, functionality, and quality of life. as secondary measures, we propose to compare the effects of these exercise programs on measures of executive function (ef), sleep, disease stage, motor symptoms, muscle quality, rigidity, strength, power, and mobility.

yoga has long been recognized as a therapeutic intervention for improving mindfulness and psychological well-being. yoga represents a unique exercise activity that employs mindfulness-based practices and various balance postures to improve physical and mental health. yoga is a gentle form of exercise that can be easily adapted to populations suffering from physical and mental limitations and has been shown to improve physical and psychological functioning in individuals with pd. though research continues to support the positive psychological effects of yoga, it is unclear whether this is due to the unique mindfulness-rooted approach of yoga or general increases in physical activity. power-based resistance training has had promising results in the pd community. improvements in balance, gait, and increases in leg muscle power and strength have been shown in pd patients after power training interventions. although power training is a beneficial exercise modality in the treatment of motor symptoms, the effects of power training on nonmotor symptoms have yet to be established.

Eligibility criteria:
inclusion criteria: * diagnosed with mild to moderate pd \[hoehn and yahr (h\&y) stage 1-3\]; * over 50 years of age; * stable use of medication; * able to walk 15 m independently with or without an assistive device; * the ability to get up and down from the floor with minimal assistance; * not currently participating in yoga or resistance training more than one time per week; * able to understand and communicate in english; and, * able to provide informed consent. exclusion criteria: * cognitive impairment as designated by a score of less than 23 on the montreal cognitive assessment (moca)\]; and, * any clinically significant medical condition, such as cardiopulmonary disease and musculoskeletal problems. subjects providing affirmative answers on a physical activity readiness questionnaire (par-q) or health status questionnaire related to cardiopulmonary disease or musculoskeletal impairments will be required to present a physical activity clearance from their physician.

Keywords: parkinson's disease
spacer graft study

Conditions: Eyelid Diseases; Eyelid Droop

Summary: to determine which of three types of spacer grafts (hard palate vs autologous ear cartilage vs enduragen) are the most effective in lower eyelid retraction repair outcomes as measured by mrd2 (margin to reflex distance 2)

lower eyelid retraction is a common eyelid malposition, typically caused by thyroid eye disease, excessive resection of skin in a cosmetic lower eyelid blepharoplasty, vertical rectus muscle recession, facial nerve paralysis, or a normal anatomical variant. when the lower eyelid is displaced inferiorly, exposing sclera between the limbus and the eyelid margin, symptoms can vary from ocular irritation and discomfort to vision threatening corneal decompensation. if medical management does not suffice, surgery is indicated. although lower eyelid retractor lysis alone has been described, supporting material (spacer graft) placed to augment the posterior lamella is generally required for more effective elevation of the eyelid. various materials have been utilized, including autologous auricular cartilage, bovine acellular dermal matrix, porcine acellular dermal matrix, hard palate mucosa, dermis and dermis fat grafts. previous studies on acellular dermal matrix use in lower eyelid retraction repair consist of retrospective efficacy studies with only 2 comparative studies. however, conflicting results raised doubt as to which material was superior. in addition, a prospective, randomized comparative study of spacer grafts used for lower eyelid retraction repair was done comparing autologous auricular cartilage, porcine acellular dermal matrix, and bovine acellular dermal matrix. the results yielded no statistically significant difference in surgical outcomes and complications. as of now, surgery with any of the spacer grafts, including autologous hard palate, is accepted as standard of care. this study is designed to determine whether using hard palate as a spacer graft will have statistically significant different surgical outcomes and complications as compared to autologous ear cartilage and porcine acellular dermal matrix spacer grafts. although studied separately, this has not been studied before in a prospective randomized manner and may prove to demonstrate improved surgical results and decreased complications. this can guide future choice of spacer graft used in lower eyelid retraction repair surgery.

Eligibility criteria:
inclusion criteria: * underwent lower eyelid retraction repair requiring a spacer graft between july 1, 2019 and july 1, 2022 exclusion criteria: * younger than 18 years old * required concurrent surgeries (e.g., midface lift or full thickness skin graft) or required further surgeries on the operated eyelid within the 6 months postoperatively * patients with less than 1-month follow up will be excluded from all outcome analysis and those without postoperative 6-month data will be excluded from the postoperative month 6 mrd2 calculation

Keywords: retraction repair hard palate autologous ear cartilage porcine acellular dermal matrix spacer graft
clinical efficacy of tnf-kinoid in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the safety and immunogenicity of the tnf-kinoid (tnf-k) have been evaluated in a phase ii clinical study conducted in subjects with rheumatoid arthritis. preliminary results of clinical efficacy are promising. the principal aim of the present study is to confirm the clinical efficacy of the tnf-k in subjects with rheumatoid arthritis in whom treatment with methotrexate is not working anymore. subjects who have never been treated with anti-tnfα monoclonal antibodies will be enrolled in this trial. in addition, the immune responses and the safety elicited by tnf-k will also be evaluated.


Eligibility criteria:
inclusion criteria: * has had a diagnosis of ra according to the revised acr criteria (aletaha et al. 2010) for at least 6 months. * has been treated with and tolerated mtx for at least 3 months prior to the first administration of study product, - has at least four swollen joints/66 and/or four tender joints/68, * has crp ≥ 10 mg/l at screening. * is positive for rheumatoid factor (rf) or anti-cyclic citrullinated peptides (ccp) antibodies at screening. exclusion criteria: * has inflammatory rheumatic disease other than ra * has been treated with non-biological dmards/systemic immunosuppressives * has been treated with leflunomide within 12 weeks prior to first administration of study product. * has received intra-articular, intramuscular (im), or intravenous (iv) corticosteroids * has received infliximab, etanercept, adalimumab, certolizumab, golimumab; another tnfα antagonist; or rituximab prior to the study. * has been treated with any other biological dmards
tofogliflozin glp-1 analogue combination trial

Conditions: Type 2 Diabetes Mellitus

Summary: an open-label, multicenter study to evaluate 52-week long-term safety, tolerability and efficacy of tofogliflozin with glp-1 analogue treatment in type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * the subject aged from 20 to 75 years old with type 2 diabetes mellitus(t2dm) * the subject with hemoglobin a1c ≧7.5% - \<10.5 % * the subject who has been receiving a stable dose and regimen of glp-1 analogue over 8 weeks before screening test exclusion criteria: * the subject with type 1 diabetes mellitus * the subject with pregnancy or lactation * the subject with fasting plasma glucose ≧ 270 mg/dl * the subject with history of metabolic acidosis, including diabetic ketoacidosis ,within 1 year prior to screening * the subject with myocardial infarction, stroke, or heart failure requiring hospitalization or drug or alcohol abuse within the previous 6 months * the subject with serum creatinine level greater than 2.0 mg/dl for men and 1.5 mg/dl for women * the subject with aspartate aminotransferase(ast) or alanine aminotransferase(alt) ≧ 2.5 times the upper limit of the reference range at the central laboratory test facility * the subject has received treatment with another investigational product or non-approved drug 3 months before screening * the subject with history of tofogliflozin therapy * the subject with estimated glomerular filtration rate of \<30 ml/min/1.73 m\^2 * the subject who frequently experiencing orthostatic hypotension * the subject systolic blood pressure of ≧ 180 or mmhg of diastolic blood pressure of ≧ 100 mmhg * the subject required a change in the dosing regiment for the following drugs within 4 weeks before screening : lipid-lowering drug , antihypertensive drug, thyroid hormone drug , uric acid lowering drug
utilization of confocal microscopy during cardiac surgery

Conditions: Atrial Septal Defect

Summary: the investigators propose to translate confocal microscopy for use during open heart surgery. this tool will help discriminate between various types of tissues in the heart during surgery. one of the most feared complication after heart surgery is heart block. this flexible fiberoptic confocal microscope will help discriminate between the various types of tissues in the heart and thus help avoid injury to the conduction tissue during surgery.

this is an interventional pilot study that proposes to evaluate the safety, logistical feasibility, and technological feasibility of using fluorescite with fiberoptic confocal microscopy during cardiac surgery to discriminate between cardiac tissue and conduction tissue. during surgery to repair atrial septal defect, diluted fluorescite will be added to the surface of the heart. the fiberoptic confocal microscope (cellvizio 100 series system with confocal miniprobe) will be used to record images in several different locations of the heart. the image files will be provided to blinded raters who will attempt to identify whether they contain cardiac tissue or conduction tissue. all subjects will be monitored while they are inpatient after surgery for any adverse events.

Eligibility criteria:
inclusion criteria: * males and females between 30 days and 21 years old * undergoing elective surgery for closure of atrial septal defect * both parents attend pre-operative clinic appointment, to provide 2 parent consent, or an adult participant (age 18-21) may provide consent for him/herself exclusion criteria: * prior history of adverse reaction to fluorescein sodium * prior history of renal failure or abnormal renal function * baseline pr interval \> 220 msec or 98% for age * baseline hr \> 87% for age * underlying genetic syndrome associated with progressive av block of sinus node dysfunction (e.g. holt-oram or nkx2.5)
concurrent subcutaneous basal insulin and intravenous insulin pump in hyperglycemic crisis patients under critical care

Conditions: Hyperglycaemic Crisis in Diabetes Mellitus; Diabetic Ketoacidosis; Hyperglycaemic Hyperosmolar Nonketotic Syndrome

Summary: the safety and efficacy of basal insulin during intravenous insulin infusion for hyperglycemic crisis patients under critical care is still unknown. we assumed that concurrent basal insulin subcutaneous injection and intravenous insulin infusion for critically ill dka and hhs patients would shorten the time of hyperglycemic crisis correction and achieved better glycemic control(decrease hypoglycemia and rebound hyperglycemia).

diabetic ketoacidosis (dka) and hyperosmolar hyperglycemic state (hhs) are hyperglycemic crises sharing similar clinical features including hyperglycemia, dehydration and electrolytes abnormalities. hyperglycemia results from relative deficient circulating insulin and oversecretion of glucagon, catecholamines, cortisol, and growth hormone. glycosuria induced osmotic diuresis leads to dehydration and electrolyte abnormalities. diabetic ketoacidosis is also characterized by increased gluconeogenesis, lipolysis, ketogenesis, and decreased glycolysis.\[1\] in critically ill and mentally obtunded patients with dka or hyperosmolar hyperglycemia, continuous intravenous insulin is the standard of care.\[2\] administration of subcutaneous insulin glargine during intravenous insulin infusion shortened the time of dka correction and significantly decreased hyperglycemia after discontinuation of the intravenous insulin. \[3, 4\]the differences in rebound hyperglycemia rates were highly significant for at least 12 hours after transition to subcutaneous insulin regimens in the dka and non-dka patients as well as in organ transplant patients receiving steroids. \[4\] however, the previous studies only enrolled small numbers of patients(without asian population) and excluded newly diagnosed hyperglycemia or critical illness and pregnant women. the safety and efficacy of basal insulin during intravenous insulin infusion for hyperglycemic crisis patients under critical care is still unknown. the investigators assumed that concurrent basal insulin subcutaneous injection and intravenous insulin infusion for critically ill dka and hhs patients would shorten the time of hyperglycemic crisis correction and achieved better glycemic control(decrease hypoglycemia and rebound hyperglycemia).

Eligibility criteria:
inclusion criteria: * patients with hyperglycemic crisis(dka, hhs or mixing type) receiving iv insulin infusion * patients admitted to the changhua christian hospital medical intensive care unit(micu) exclusion criteria: * pregnancy * age under 18 years old

Keywords: hyperglycemic crisis dka hhs insulin pump basal insulin critical care
comparison of ultrasound guided versus blind corticosteroid injection for trochanteric bursitis

Conditions: Bursitis

Summary: trochanteric bursitis is a common condition, effecting 20% of the population. \\most with trochanteric bursitis experience chronic intermittent or continuous hip pain at and around the greater trochanter. the cause of trochanteric bursitis is believed to be a result of inflammation of the bursa, though this has not been confirmed. accordingly, the use of corticosteroid injections has been shown to provide considerable relief. however, routine "blind" injections, those performed without the aid of imaging, such as fluoroscopy, have shown limited success in the appropriate needle placement. fortunately, blind injections have yielded positive results in majority of the cases. additionally, the use of fluoroscopy has not shown to improve clinical outcome for trochanter bursa injections. although the use of fluoroscopy has not shown positive benefit, other modes of imaging, such as ultrasound have not been studied and may be more useful. fluoroscopy allows for bony-landmark based injections. ultrasound allows for direct visualization of the soft tissue structures such as the bursa and has gained significant support for use in musculoskeletal injections. this prospective blinded study's aim is to evaluate, if any, the benefit of an ultrasound guided injection and whether ultrasound should be routinely used during trochanter bursa injections.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of trochanteric bursitis 2. 18 years of age or older when written informed consent is obtained 3. signed institutional review board (irb) approved informed consent form exclusion criteria: 1. allergy to triamcinolone or bupivicaine 2. coagulopathy 3. active infection 4. currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments
assessment of endoscopic tip control using a novel score based on the snare tip soft coagulation of polypectomy margin defects

Conditions: Colorectal Polyp

Summary: colorectal cancer is the third most common malignancy worldwide and the second leading cause of cancer related death with approximately 880 792 deaths every year (9,2% of the global yearly 9.6 million cancer deaths). screening for polyps is done by colonoscopy, which is considered the gold standard for screening and removal of polyps and has been proven to reduce the global colorectal cancer burden significantly. endoscopic removal of polyps is preferred because of its efficiency, cost-effectiveness, and safety in comparison to surgery. endoscopic tip control is a fundamental component of high quality endoscopy. endoscopic procedures are complex processes where cognitive processing and motoric output need to be perfectly aligned. this is reflected in endoscopic tip control. it is indispensable in every step of endoscopy: during insertion of the endoscope, where the tip of the endoscope needs to reach the caecum/terminal ileum/duodenum, without discomfort for the patient if under light sedation, during withdrawal of the endoscope in order not to miss any lesions, and also during every endoscopic treatment whether it is a simple polypectomy or a complex therapeutic procedure performed by expert endoscopists. however, there is currently no tool available to assess endoscopic tip control. and very little is known about educating it. the investigators developed a new, web-based scoring system to assess tip control. the intent of this study is to validate this novel tool so it can be used to assess endoscopists and evaluate their progress when training in endoscopy. this study takes place at the university hospital ghent, which is a tertiary care center for gastrointestinal endoscopy. the investigators will validate the tool in this study, through assessment of endoscopists of varying experience while they use a technique of snare tip soft coagulation on the margin of a polypectomy defect. this technique has proven its use in preventing recurrence after polypectomy. the technique uses the tip of a snare (used to resect polyps) to deliver thermal energy to the margin of a polypectomy, also called margin ablation. thermal energy is applied by a hit on a pedal (operated with the foot), every hit needs to be exactly on the margin of the defect (not in the defect, not on normal mucosa around the defect). this requires a very steady and controlled handling of the endoscope and is an ideal technique to assess endoscopist's tip control. the score system will calculate the accuracy (number of correct hits over number of wrong hits) of tip control per second.


Eligibility criteria:
inclusion criteria: * endoscopists who perform endoscopic mucosal resections (emr) at the university hospital of ghent, belgium (uz gent) * patients, \> 18 years of age, referred for emr needing snare tip soft coagulation of the defect margins. exclusion criteria: * endoscopists who do not consent to the study * patients who do not consent to the study

Keywords: endoscopy training polypectomy
shortened aggrastat® versus integrilin in percutaneous coronary intervention

Conditions: Myocardial Infarction; Acute Coronary Syndromes; Unstable Angina

Summary: the purpose this study is to assess whether a tirofiban regimen of a high-dose bolus plus a shortened infusion duration compared to label-dosing eptifibatide in patients undergoing percutaneous coronary intervention (pci) is associated with a non-inferior composite rate of death, pci-related myocardial infarction, urgent target vessel revascularization or in-hospital major bleeding within 48 hours following pci or hospital discharge, whichever comes first.


Eligibility criteria:
inclusion criteria: * age ≥18 years of age * scheduled to undergo pci with an fda, approved or cleared device (stent or procedures such as balloon angioplasty, rotoblation, angiosculpt, laser atherectomy,etc.) in one or more native coronary target lesions * written informed consent exclusion criteria: * primary pci for stemi as index procedure * prior stemi within 48 hours before randomization * prior pci within 30 days before randomization * planned staged pci within the subsequent 24 hours after index pci * use of abciximab within 7 days before randomization * use of tirofiban or eptifibatide within 12 hours before randomization * use of low-molecular weight heparin within 12 hours before randomization * use of bivalirudin within 12 hours before randomization